Shock Wave Therapy for Sural Myofascial Pain Associated to Chronic Heel Pain

NCT ID: NCT04385329

Last Updated: 2020-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-04
• Study Completion Date: 2018-11-03

Brief Summary

The aim of this randomized controlled study in to investigate if a shock wave treatment extended to the gastrocnemius-soleus trigger points (TrP) is more effective than a standard treatment exclusively targeted at the plantar fascia in a population affected by unilateral plantar fasciitis with concomitant sural myofascial pain syndrome.

Conditions

Tendinopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental group:shock waves extended to gastrocnemius TrP

Focused shock wave therapy was extended from the plantar fascia to the gastrocnemius-soleus trigger points.

Group Type: EXPERIMENTAL

Shock wave therapy on plantar fascia extended to the gastrocnemius-soleus trigger points

Intervention Type: OTHER

Enrolled subjects were treated with focused shock wave therapy, once a week for three consecutive weeks, by a specialized physician with more than five years of expertise, using a device powered by a piezoelectric generator (PIEZOSON 100PLUS, Richard Wolf®). At each treatment session, with the patients lying in prone decubitus position, the enthesis of the plantar fascia and the gastrocnemius-soleus trigger points were clinically targeted and treated with a perpendicular technique.

Control group: shock waves not extended to gastrocnemius TrP

A standard focused shock wave therapy exclusively targeted at the plantar fascia

Group Type: ACTIVE_COMPARATOR

Shock wave therapy on plantar fascia only

Intervention Type: OTHER

Enrolled subjects were treated with focused shock wave therapy, once a week for three consecutive weeks, by a specialized physician with more than five years of expertise, using a device powered by a piezoelectric generator (PIEZOSON 100PLUS, Richard Wolf®). At each treatment session, with the patients lying in prone decubitus position, the enthesis of the plantar fascia was clinically targeted and treated with a perpendicular technique.

Interventions

Shock wave therapy on plantar fascia extended to the gastrocnemius-soleus trigger points

Enrolled subjects were treated with focused shock wave therapy, once a week for three consecutive weeks, by a specialized physician with more than five years of expertise, using a device powered by a piezoelectric generator (PIEZOSON 100PLUS, Richard Wolf®). At each treatment session, with the patients lying in prone decubitus position, the enthesis of the plantar fascia and the gastrocnemius-soleus trigger points were clinically targeted and treated with a perpendicular technique.

Intervention Type: OTHER

Shock wave therapy on plantar fascia only

Enrolled subjects were treated with focused shock wave therapy, once a week for three consecutive weeks, by a specialized physician with more than five years of expertise, using a device powered by a piezoelectric generator (PIEZOSON 100PLUS, Richard Wolf®). At each treatment session, with the patients lying in prone decubitus position, the enthesis of the plantar fascia was clinically targeted and treated with a perpendicular technique.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adult age (18 to 75 years) and written informed consent;
• Unilateral heel pain of four weeks or longer duration;
• Pain to digital pressure in the insertional area of the plantar fascia at the calcaneum;
• Sonographic examination showing a plantar fascia thickness greater than 3.8mm (see procedures for details);
• Concomitant presence of a sural myofascial pain syndrome (SMPS), diagnosed on the basis of the finding, at the physical examination, of trigger points of the gastrocnemius-soleus muscle complex, according to Travel and Simons' original description.

Exclusion Criteria

• No corticosteroid injections or other physical therapies since the onset of the current pain episode (except pharmacological pain treatments and foot orthoses);
• No general contraindication to shock wave therapy (pregnancy, bleeding disorders or anticoagulant drug usage, cancer in the focal area);
• No clinical signs of lumbar radiculopathy at physical examination;
• No ankle osteoarthritis, diagnosed on the basis of clinical and radiographic findings;
• No previous fractures or surgery in the affected ankle and foot;
• No rheumatologic diseases, no plantar fibromatosis

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

Sponsor Role: lead

Responsible Party

Ettore Carlis

Physician specialised in physical medicine and rehabilitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

20160017179

Identifier Type: -

Identifier Source: org_study_id